Back to resultsNovel Dose Adjustment Schedule for Late Injection in SCIT in AR
Primary Purpose
Allergic Rhinitis, Immunotherapy
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Novel dose adjustment of Alutard SQ
conventional dose adjustment of Alutard SQ
Routine continuous cluster of Alutard SQ
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- (1) aged 18 to 60 years;
- (2) only had a positive response to Der p and Der f but no other inhalant allergens based on EUROline Allergy Diagnostics (Beijing Oumeng Biotechnology Co., Ltd., Beijing, China). Meanwhile at least Der p -specific IgE (sIgE) in serum of was ≥ 0.7 kU/l (CAP Pharmacia, Uppsala, Sweden) using ImmunoCAP system (Pharmacia, Uppsala, Sweden) regardless of the result of Der p -specific IgE in serum;
- (3) had reached cluster SCIT maintenance period and the overall treatment time was more than 1 year but less than 2 years;
- (4) hope to continue to complete the entire treatment and have good compliance.
Exclusion Criteria:
- (1) diagnosed as asthma based on the guidelines of the Global Initiative for Asthma(13);
- (2) had Grade II or above systemic adverse reactions occurred in the past SCIT period.
Sites / Locations
- Beijing Tongren Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Novel dose adjustment schedule
Conventional dose adjustment
Continuous cluster SCIT schedule
Arm Description
The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with novel dose adjustment schedule.
The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with conventional dose adjustment schedule.
The subjects had a routine cluster SCIT schedule without interrupted period.
Outcomes
Primary Outcome Measures
The change of Combined Symptom and Medication Score
CSMS which was calculated as follows: (total nasal symptom scores (TNSS))/4+ MS as recommended by European Academy of Allergy and Clinical Immunology (EAACI) Position Paper. The CSMS score was 0-6, 0 for good therapeutic effect and 6 for poor therapeutic effect.
Secondary Outcome Measures
The change of total nasal symptom scores
last 7 days' overall symptom scores of major nasal symptoms (nasal obstruction, nasal itching, sneezing, and rhinorrhea: 0, no symptoms; 1, mild; 2, moderate; 3, serious). TNSS scores was 0 to 12 (0 = no symptoms;12 = most severe symptoms).
The change of medication score
MS was calculated as follows: 1, oral Clarityne tablet; 2, intranasal Budesonide nasal spray.
Adverse reactions
The patients were instructed to immediately report to the physician if any symptom appeared or adverse reactions occurred during the observation period. The time and severity of onset, estimation of a possible reason, resolution, and outcome should be recorded. The adverse reactions were classified in terms of the localization (local or systemic) and the time of appearance (immediate or delayed). Local reactions (LRs) were expressed as the length of the wheal diameter. Systemic reactions (SRs) were graded in accordance with the standards of the EAACI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04929093
Brief Title
Novel Dose Adjustment Schedule for Late Injection in SCIT in AR
Official Title
Comparative Study of Novel and Conventional Dose Adjustment Schedules for Late Injection of More Than 16 Weeks in Subcutaneous Immunotherapy in Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
April 16, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Allergen specific immunotherapy is currently the only curative intervention for allergic rhinitis (AR). Subcutaneous immunotherapy (SCIT) need to be reinstituted with an interruption of more than 16 weeks in maintenance period, leading to increased time and economic cost burden and difficulties for continuing further treatment for patients. The aim of present study was to develop a novel dose adjustment schedule for such situation and to compare the clinical efficacy and adverse reactions between novel and conventional schedules for dust mite (DM) SCIT of AR subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Novel dose adjustment schedule
Arm Type
Experimental
Arm Description
The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with novel dose adjustment schedule.
Arm Title
Conventional dose adjustment
Arm Type
Active Comparator
Arm Description
The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with conventional dose adjustment schedule.
Arm Title
Continuous cluster SCIT schedule
Arm Type
Active Comparator
Arm Description
The subjects had a routine cluster SCIT schedule without interrupted period.
Intervention Type
Biological
Intervention Name(s)
Novel dose adjustment of Alutard SQ
Intervention Description
novel dose adjustment schedule means directly reaching dose of Vial 4, 10,000 SQ
Intervention Type
Biological
Intervention Name(s)
conventional dose adjustment of Alutard SQ
Intervention Description
conventional dose adjustment schedule means restarting from dose of Vial 1, 10 SQ
Intervention Type
Biological
Intervention Name(s)
Routine continuous cluster of Alutard SQ
Intervention Description
Patient receiving continuous cluster SCIT for DM during the same period
Primary Outcome Measure Information:
Title
The change of Combined Symptom and Medication Score
Description
CSMS which was calculated as follows: (total nasal symptom scores (TNSS))/4+ MS as recommended by European Academy of Allergy and Clinical Immunology (EAACI) Position Paper. The CSMS score was 0-6, 0 for good therapeutic effect and 6 for poor therapeutic effect.
Time Frame
baseline, week 3, week 6, week 26.
Secondary Outcome Measure Information:
Title
The change of total nasal symptom scores
Description
last 7 days' overall symptom scores of major nasal symptoms (nasal obstruction, nasal itching, sneezing, and rhinorrhea: 0, no symptoms; 1, mild; 2, moderate; 3, serious). TNSS scores was 0 to 12 (0 = no symptoms;12 = most severe symptoms).
Time Frame
baseline, week 3, week 6, week 26.
Title
The change of medication score
Description
MS was calculated as follows: 1, oral Clarityne tablet; 2, intranasal Budesonide nasal spray.
Time Frame
Baseline, week 26.
Title
Adverse reactions
Description
The patients were instructed to immediately report to the physician if any symptom appeared or adverse reactions occurred during the observation period. The time and severity of onset, estimation of a possible reason, resolution, and outcome should be recorded. The adverse reactions were classified in terms of the localization (local or systemic) and the time of appearance (immediate or delayed). Local reactions (LRs) were expressed as the length of the wheal diameter. Systemic reactions (SRs) were graded in accordance with the standards of the EAACI
Time Frame
week 26.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1) aged 18 to 60 years;
(2) only had a positive response to Der p and Der f but no other inhalant allergens based on EUROline Allergy Diagnostics (Beijing Oumeng Biotechnology Co., Ltd., Beijing, China). Meanwhile at least Der p -specific IgE (sIgE) in serum of was ≥ 0.7 kU/l (CAP Pharmacia, Uppsala, Sweden) using ImmunoCAP system (Pharmacia, Uppsala, Sweden) regardless of the result of Der p -specific IgE in serum;
(3) had reached cluster SCIT maintenance period and the overall treatment time was more than 1 year but less than 2 years;
(4) hope to continue to complete the entire treatment and have good compliance.
Exclusion Criteria:
(1) diagnosed as asthma based on the guidelines of the Global Initiative for Asthma(13);
(2) had Grade II or above systemic adverse reactions occurred in the past SCIT period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luo Zhang
Organizational Affiliation
Beijing Tongren Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Learn more about this trial
Novel Dose Adjustment Schedule for Late Injection in SCIT in AR
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